Market Authorization

 
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Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for nivolumab in non-small cell lung cancer (NSCLC) – the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type.
Sign-up for European Medicines Agency Validates the Marketing Authorization Application for Nivolumab in Non-Small Cell Lung Cancer investment picks
RHB-102, newly branded as BEKINDA ™ , is a proprietary once-daily oral pill formulation of the antiemetic drug ondansetron The European marketing authorization application (MAA) seeks approval of BEKINDA ™ for cancer patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting BEKINDA ™ is also being developed for acute gastroenteritis and gastritis, with a Phase III study ongoing in the U.S. and top-line data expected during H2/2015 TEL-AVIV, Israel, Dec.
Sign-up for RedHill Biopharma Submits BEKINDA(TM) (RHB-102) European Marketing Authorization Application for Oncology Support investment picks
Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) of ELOCTA ™ (rFVIIIFc), a recombinant factor VIII Fc fusion protein product candidate for the treatment of hemophilia A.
Sign-up for Biogen Idec and Sobi Announce European Medicines Agency Validates ELOCTA™ (rFVIIIFc) Marketing Authorization Application for Review investment picks
NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the European Medicines Agency (EMA) has validated and initiated its review of the company’s marketing authorization application (MAA) for Natpar ® (parathyroid hormone (rDNA)) for the treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone (PTH). If approved, Natpar would be the first and only PTH replacement therapy in Europe for patients with Hypoparathyroidism.
Sign-up for European Medicines Agency Validates Marketing Authorization Application for Natpar® (parathyroid hormone (rDNA)) in Hypoparathyroidism investment picks
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for Zydelig ® (idelalisib), 150 mg tablets, a first-in-class oral treatment for two incurable blood cancers - chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). For the treatment of CLL, Zydelig has been approved for use in combination with rituximab for patients who have received at least one prior therapy; or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Sign-up for European Commission Grants Marketing Authorization for Gilead’s Zydelig® (Idelalisib) for the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma investment picks
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for Harvoni ® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults.
Sign-up for European Commission Grants Marketing Authorization for Gilead’s Harvoni®▼ (Ledipasvir/Sofosbuvir), the First Single Tablet Regimen to Treat the Majority of Chronic Hepatitis C Patients With Genotype 1 and 4 investment picks
pSivida Corp.
Sign-up for pSivida Reports ILUVIEN® Granted Marketing Authorization in Ireland investment picks
pSivida Corp.
Sign-up for pSivida Reports ILUVIEN® Granted Marketing Authorization in Belgium investment picks

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Market Authorization
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